New England Compounding Center's contaminated drugs caused a fungal meningitis outbreak that killed more than 60 people.

With stellar vaccine sales for GlaxoSmithKline and Bexsero, GSK is building a $175 million plant in Germany to expand production of the meningococcal B shot.

Valeant Pharmaceuticals International said today that it has gotten a new PDUFA date for its eye drug candidate latanoprostene bunod, which the FDA sidelined…

Nigeria has been looking for ways to get more drugs manufactured in the country while Servier’s generics unit Biogaran has been looking to expand. Now both…

Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice.

The FDA last month issued a warning letter to Pfizer for a sterile injectables plant in Kansas. Now the FDA has posted details of the inspection that led to…

Mylan is recalling lots of the Type 2 diabetes med Glipizide and the antidepressant Mirtazapine after stray tablets were discovered in bottles of the meds.

Placing a company on the FDA import alert list does not guarantee its products won't get into the U.S., as a recent warning letter shows.

The FDA said in a warning letter that an Indian API maker had not ensured that water it gets from a nearby river is sanitary before using it to make its…

Manufacturing